The Continuous Glucose Monitoring System (CGMS) is indicated for continuous or regular monitoring of glucose levels in subcutaneous tissue, and is used for daily detection and self-management of blood glucose levels in people 2 years and older. It is intended for use by patients at home and in healthcare facilities. Interpretation of the CGMS results should be based on the glucose trends and several sequential readings over time. The CGMS also aids in the detection of episodes of hyperglycemia and hypoglycemia, and facilitating therapy adjustments. The System is designed to replace fingerstick blood glucose (BG) testing.